Replacement of rabbit pyrogen testing by an alternative test for plasma derived medicinal products

Current effective version

PDF iconAdopted guideline

Reference number CHMP/BWP/452081/07
Published 23/04/2009
Effective from 01/11/2009
Keywords Plasma derived medicinal products, rabbit pyrogen testing, bacterial endotoxin test, LAL test, monocyte activation test
Description This document lays down the requirements to be addressed in any justification for use of a test for bacterial endotoxins as an alternative to a test for pyrogens for plasma derived medicinal products. It specifically, addresses the LAL-testing related issues, process related considerations, clinical considerations and regulatory aspects to be considered when replacing the test for pyrogens by an alternative test.


Document history

First version

Current version

PDF iconAdopted guideline

 

PDF iconOverview of comments

 

PDF iconDraft guideline

In operation: 01/11/2009–present

 

Published: 23/04/2009

 

Published: 05/12/2007


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